Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)

This study is currently recruiting participants.
Verified May 2013 by Seoul National University Hospital
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital Identifier:
First received: April 12, 2013
Last updated: May 8, 2013
Last verified: May 2013

The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.

Condition Intervention Phase
Very Low Birth Weight Infant
Ureaplasma/Mycoplasma Positive
Drug: Clarithromycin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 72 hours after first infusion ] [ Designated as safety issue: No ]
    AUC, Cmax

Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clarithromycin
Population PK
Drug: Clarithromycin
IV clarithromycin infusion


Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • birthweight < 1500gm
  • transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)

Exclusion Criteria:

  • sepsis, hypotension, shock
  • major congenital anomaly
  Contacts and Locations
Please refer to this study by its identifier: NCT01851954

Contact: Seung Han Shin, MD

Korea, Republic of
Seoul National University Children's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung Han Shin, MD   
Principal Investigator: Han-Suk Kim, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Han-Suk Kim Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital Identifier: NCT01851954     History of Changes
Other Study ID Numbers: clarith_VLBW
Study First Received: April 12, 2013
Last Updated: May 8, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Birth Weight
Mycoplasma Infections
Body Weight
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses processed this record on April 15, 2014